Objective
This annual conference aims at keeping legal practitioners working with the pharmaceutical sector up-to-date on the latest relevant regulatory developments, legislative initiatives and case law. A particular focus will be on implications for the sector of recent EU activities in the fields of competition law, intellectual property, data protection and privacy as well as pharmaceutical law.
Key topics
Competition law and patents
- Reverse payment settlements in the US and in Europe and current activities from the European Commission in the field of competition law
- Interim and cross-border injunctions against infringement of pharmaceutical patents
- Preparing for the EU unitary patent system: update on recent developments
Data protection and privacy
- Access to clinical trials data: the General Court decision in InterMune (T-73/13R)
- Proposal for modification of the General Data Protection Regulation (COM(2012)11): implications for the life science sector
- Cloud computing health services and data protection
EU pharmaceutical law round-up
- Update on EU legislative proposals: clinical trials, in vitro diagnostics, orphan drugs
- Major developments in the fight against falsified medicinal products
- Drug device combination products and data exclusivity
- Off-label use and the CJEU case Novartis Pharma v Apozyt (C-535/11)
- Orphan medicinal products and the recent decision in Laboratoires CTRS (T-301/12)
Who should attend?
In-house counsel and legal or patent advisers in pharmaceutical companies; lawyers in private practice dealing with pharmaceuticals and medical devices; lawyers in national ministries and authorities dealing with regulation of the sector.
Fees in €:
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Standard
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EU and ERA patrons
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Young lawyers and other groups
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Registration
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More details about the fees and discounts
Early registration discount
10 % before 27.01.2014
Discounts available
25 % - For young lawyers up to 30 years of age (important: the participant must provide a copy or details of his or her passport or identity card on registration); Full-time staff of universities or comparable academic institutions; Staff of charitable organisations or comparable institutions
40 % - Staff of European Union institutions and agencies;
Staff of ERA’s patrons (Austria, Bulgaria, Croatia, Cyprus, Czech Republic, Finland, France, Germany and the German states, Greece, Hungary, Ireland, Italy, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Scotland, Slovakia, Slovenia, Spain, Sweden, United Kingdom, City of Trier)